DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Study ID
NCT07322237
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cardiometabolic Risk Factors
  • Cirrhosis
  • Cirrhotic Cardiomyopathy
  • Empagliflozin

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin + Carvedilol — DRUG
    Patient Recruitment: The study participants are all cirrhosis patients receiving treatment at PGIMER Chandigarh. Eligible participants meeting LVDD criteria per the CCM Consortium 2020 consensus. Carvedilol Dosing protocol in this study Patients will be given carvedilol in a starting dose of 3.125 mg twice daily. The dose will be titrated weekly to achieve a target heart rate of 50-60/ min taking care that side effects such as hypotension bronchospasm excessive bradycardia are not seen. The maximum dosage allowed as per prior trial data is 25 mg per day. Empagliflozin Dosing protocol in this Study: • All patients will receive a standard dose of Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes.
  • Carvedilol — DRUG
    * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo pill * Standard Medical Therapy

Study Details

1. This proposed double-blind placebo controlled randomized controlled trial incorporates recent advances in management of heart failure and portal hypertension using the SGLT-2 inhibitor i.e. EMPAGLIFLOZIN. The drug has been found to be useful in large trials on heart failure with preserved ejection fraction in the general population with improvement in MASLD progression, with improvement in body weight and hepatic steatosis but no change in liver fibrosis. 2. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the development and progression of heart failure in patients with type 2 diabetes and in those with heart failure and a reduced and preserved ejection fraction. In patients with cirrhosis safety of empagliflozin in a dose of 10 mg has been demonstrated. 3. Prevention of decompensation related events in cirrhosis is the key endpoint of any liver-directed therapy as the median survival in the compensated state exceeds 10 years but median survival in the decompensated state approximates 1.5 years. Previous data has demonstrated the risk of hepatic decompensation acute kidney injury and poor survival in patients with cirrhosis and heart failure with preserved ejection fraction (HFpEF) i.e. LVDD a large subset of whom meet criteria for CCM.

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Jan 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Experimental: Empagliflozin + Carvedilol-arm
    Experimental: Empagliflozin + Carvedilol-arm * Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes for 1 year from randomization * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate * Standard Medical Therapy for liver disease as per clinician decision
  • Active Comparator: Active Comparator: Carvedilol arm
    * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo administered once daily. * Standard Medical Therapy prescribed as per clinician decision

Primary Outcome Measure

Composite end point of decompensation event and/or death [ Time Frame: From enrolment through study completion, an average of 1 year ]

Central Contacts

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